Preterm Immune System Development and Response to Immunization (PRIMI)

Maastricht University Medical Centre (MUMC)

Status

Enrolling

Conditions

Vaccination Failure

Immune System Disorder

Preterm

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05266664

NL80118.068.22

Details and patient eligibility

About

In this study the response to vaccination and development of the immune system in very preterm infants upon the current vaccination schedule will be compared to healthy term infants.

Full description

Preterm infants are at increased risk of developing infections early in life due to a less mature immune system compared to full-term infants. Moreover, protection by the placental transfer of maternal antibodies in general and specifically against vaccine antigens has shown to be significantly lower in very preterm infants (gestational age (GA)< 32 weeks) compared to term infants. In this study we aim to investigate the immune system development of very preterm infants. Adequate immune response to vaccination is considered both clinically important as well as a functional test of the immune system. However, data on the antibody and Ag-specific memory B cell response to vaccination in preterm infants are limited.

Primary objective is to study the antibody immune response to routine vaccinations in very preterm infants (GA<32 weeks). Secondary aim is to study the immune system more extensively using flow cytometry, ELISA and single cell transcriptomics to measure development of Ag-specific memory B cells raised in response to vaccination, and by using proteomics, epigenetics, and microbiome studies.

Enrollment

145 estimated patients

Sex

All

Ages

1 day to 2 months old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

To be eligible to participate in this study, a preterm infant must meet all following criteria:

Preterm infant born at gestational age less than 32 weeks (whose mothers did or did not receive a T dap vaccination during pregnancy)
Parents/ guardians must have sufficient understanding of the Dutch language

To be eligible to participate in this study, a healthy full-term infant must meet all following criteria:

healthy full-term infant whose mother received a Tdap vaccination during pregnancy
Parents/ guardians must have sufficient understanding of the Dutch language

To be eligible to participate in this study, a mother must meet all following criteria:

Mother of preterm or health full-term infant who are participating in the study

Exclusion Criteria:

Parents/guardians of the infant are not able or willing to provide informed consent
Infant with congenital anomaly which are more likely to cause adverse effects after immunization (for example hemodynamically significant congenital heart defect)
Infant with a (possible) HIV infection or immunodeficiency
Maternal use of immunosuppressive drugs during pregnancy